[Clinical evaluation of efficacy and tolerance of oral treatment with ambroxol in patients with chronic bronchitis].

This study was designed to examine the efficacy and tolerability of ambroxol (Ambrosol) on the symptomatology of chronic bronchitis among in- and out-patients. Seventy patients were included in the trial and divided into two random groups. The patients were treated in a double-blind way with either Ambrosol or a placebo for 2 months. The physician and the patient assessed the following points: the feeling general well-being, the symptoms of a cold and of fever, the need for treatment with antibiotics, the amount, viscosity and colour of sputurn, the difficulty in expectoration, the severity of coughing and any changes in breathlessness while at rest. In order to carry out these subjective assessments we used a scoring system. We observed that, breathlessness while at rest and the rate of exacerbation was significantly lower in the Ambrosol group after 2 weeks of therapy. Sputum viscosity, difficulty in expectoration and severity of coughing were reduced in this group after 4 or 8 weeks. Throughout the 2-month period of therapy, the tolerability of ambroxol was good. A total of 4 patients reported side-effects of various degrees of severity. One patient stopped the therapy due to these side-effects (dizziness). There was no significant difference in the number of side-effects between the two groups (Ambrosol vs Placebo).